Aankondiging • Jul 28
Gubra A/S Announces Initiation Of Ambitious Phase 1/2a Clinical Trial Of Lead Asset GUB-UCN2 In Obesity Gubra A/S announced the initiation of the first-in-human trial of GUB-UCN2, the company’s next mega program, with the first participant completing the first visit. The Phase 1/2a clinical trial is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of GUB-UCN2, with a particular focus on muscle volume and muscle function. The Phase 1/2a trial will enroll a total of approximately 188 healthy participants and individuals living with obesity, with and without related comorbidities. The trial consists of three parts: a single ascending dose (SAD) component, a multiple ascending dose (MAD) component, and a multiple dose (MD) component with a treatment duration of up to 16 weeks. The trial will investigate GUB-UCN2 as both a standalone therapy and in combination with incretin-based therapy for obesity. Data from the trial are expected to be released on a sequential basis, with initial data from the SAD study in healthy volunteers, including safety, tolerability, and pharmacokinetic assessments, expected in the first half of 2027. The trial is strategically designed to maximize asset value by generating multidimensional clinical data early in development and preparing the regulatory path for further development. GUB-UCN2 has delivered strong and comprehensive preclinical data. Results have shown that GUB-UCN2 substantially and selectively lowers fat mass and increases muscle mass when administered alone and in combination with incretin-based therapy. In combination with a GLP-1 receptor agonist, GUB-UCN2 completely prevented the lean mass loss typically seen with GLP-1 receptor agonist-based therapies and enhanced fat mass reduction. GUB-UCN2 also reversed lean mass loss after prior GLP-1 exposure, positioning it as both a protective and restorative therapy in treatment combination regimens. Beyond body composition, UCN2 has delivered improvements of cardiac and renal function in preclinical models. UCN2 (Urocortin 2), is a 38 amino acid neuropeptide that selectively binds to the corticotropin-releasing hormone receptor 2 (CRHR2). Activation of CRHR2 by UCN2 induces a reprogramming of skeletal muscle toward an exercise-like phenotype, leading to a favorable shift in body composition characterized by increased muscle mass and reduced fat mass. Mechanistically, UCN2 acts directly on CRHR2 receptors expressed in skeletal muscle, where it stimulates muscle growth and enhances performance. This effect is mediated in part through increased protein synthesis within muscle tissue. In parallel, UCN2 reduces intramuscular fat accumulation, contributing to improved muscle quality and metabolic efficiency. Additionally, UCN2 enhances insulin sensitivity in skeletal muscle, further supporting metabolic health and glucose homeostasis. Aankondiging • Jun 16
Gubra Announces Appointment of Lena Moran-Adams as Group General Counsel, Effective June 16, 2026 Gubra announced the appointment of Lena Moran-Adams as the company’s new Group General Counsel, effective June 16, 2026. Lena Moran-Adams joined Gubra as its new Group General Counsel responsible for driving legal strategy and execution across its business. Prior to joining Gubra, she held senior legal leadership roles at Telix Pharmaceuticals (Group General Counsel), Gilead Sciences (Head of Legal & Business Conduct, Intercontinental Region), Novartis (Global Head Legal) and Bristol Myers Squibb (Regional Senior Legal Counsel). Lena is admitted to practice law across three continents and brings more than 25 years of experience leading legal, compliance, intellectual property and corporate governance strategy teams across multiple regions and globally. Her background spans multiple practice areas, jurisdictions, and business models, ranging from start-up biotechnology companies to multinational blue-chip biopharmaceutical organizations. Aankondiging • Mar 04
Gubra A/S, Annual General Meeting, Mar 26, 2026 Gubra A/S, Annual General Meeting, Mar 26, 2026, at 10:00 Romance Standard Time. Location: horsholm kongevej 11b, 2970, Denmark Aankondiging • Jan 08
Amylyx Pharmaceuticals, Inc. Announces Nomination of Amx0318 as A Novel, Long-Acting Glp-1 Receptor Antagonist Amylyx Pharmaceuticals, Inc. announced the selection of AMX0318, a long-acting glucagon-like peptide-1 (GLP-1) receptor antagonist, as a development candidate for post-bariatric hypoglycemia (PBH) and other rare diseases. AMX0318 was identified through a research collaboration with Gubra A/S. AMX0318 has completed extensive preclinical evaluation, including stability, solubility, potency, in vivo pharmacokinetics and pharmacodynamics, and in vivo tolerability studies. Amylyx expects the program to advance into investigational new drug (IND)-enabling studies later this year, with an IND targeted for 2027, pending successful completion of IND-enabling studies. Under the terms of the research collaboration, Gubra is eligible to receive more than $50 million in success-based development and commercialization milestones plus mid-single digit royalties on worldwide net sales. The selection and handover of the development candidate will provide milestone payments of $4 million to Gubra. Aankondiging • Jan 05
Gubra Announces Executive Changes Gubra announced the appointment of Thomas Langenickel, M.D., as Chief Medical and Development Officer (CMDO) effective January 5, 2026. Dr. Langenickel brings more than two decades of experience in big pharma and biotech, spanning drug discovery, translational medicine, and clinical development. In his new role, he will join Gubra’s Leadership Team and guide the company’s preclinical and clinical development strategy as its pipeline advances toward key milestones. Dr. Langenickel most recently served as Chief Medical Officer at Ethris, where he led the development of early clinical assets in respiratory and infectious diseases. His prior experience includes senior roles at Novartis as Executive Director of Translational Medicine and Profiling, and at Bristol Myers Squibb as Medical Director. He earned his M.D. from Humboldt University of Berlin and completed a postdoctoral fellowship in vascular biology at the National Heart, Lung, and Blood Institute, NIH (USA). Gubra also extends its gratitude to Dr. Mads Axelsen, who retired in December after serving as CMO. His leadership and contributions have been instrumental in shaping Gubra's development organization and supporting the company's growth. Aankondiging • Jun 27
Gubra A/S Approves Distribution of Extraordinary Cash Dividends Gubra A/S at its EGM held on June 27, 2025, approved a distribution of extraordinary cash dividends to the Company's shareholders in the amount of DKK 1 billion, corresponding to DKK 61.2 per share of a nominal value of DKK 1. Aankondiging • Jun 03
Gubra A/S Proposes Extraordinary Cash Dividend Gubra A/S board of directors proposed that the extraordinary general meeting to be held on 27 June 2025, approves a distribution of extraordinary cash dividends to the Company's shareholders in the amount of DKK 1,000 million, corresponding to DKK 61.2 (rounded) per share of a nominal value of DKK 1. Aankondiging • Apr 04
Gubra A/S Approves Board Changes Gubra A/S in its annual general meeting held on 3 April, 2025, Henriette Dræbye Rosenquist did not stand for re-election. The Board extends heartfelt Henriette for her significant contributions wishing her all the best in her new endeavours. The Board welcomes Gubra Co-Founder and Scientific Advisor Niels Vrang's re-entry to the board and Claudia Mitchell as new members of the Board. Their collective experience in biotech innovation, research, and entrepreneurship will be a valuable asset to the next chapters in the company's growth journey. Monika Lessl, previously serving as a Board member, has been appointed as the new Chair, succeeding Jacob Jelsing, who remains an active member of the Board. As internationally experienced pharma and life science executive with more than 25 years of R&D and Innovation leadership, Monika brings visionary leadership and deep insight into innovation and sustainability - two key pillars of Gubra's mission. Aankondiging • Mar 11
Gubra A/S, Annual General Meeting, Apr 03, 2025 Gubra A/S, Annual General Meeting, Apr 03, 2025, at 10:00 Romance Standard Time. Location: horsholm kongevej 11b, dk-2970, horsholm, Denmark Aankondiging • Mar 10
Gubra A/S Announces Board Changes Gubra A/S announced Henriette Dræbye Rosenquist does not stand for re-election. The board of directors notes that Jacob Jelsing will step down as chair of the board of directors in connection
with the annual general meeting but will continue to serve as an ordinary member of the board of directors. Aankondiging • Jan 15
Gubra Appoints Anne-Marie Levy Rasmussen as Chief Operating Officer Gubra announced the appointment of Anne-Marie Levy Rasmussen as the company's new Chief Operating Officer (COO). Anne-Marie brings a strong international experience and track record from global pharma companies such as GlaxoSmithKline and Bavarian Nordic within operational leadership, scaling and establishment of solid governance routines in complex settings. Most recently as Head of Global Commercial Operations at Bavarian Nordic. As COO in Gubra, Anne-Marie will be member of the Executive Management Team and be responsible for overseeing the company's operational strategy, optimizing processes, and driving efficiency across departments and key projects. Her extensive background within leadership, scaling and system integration with new digital approaches positions her well to contribute to Gubra's continued growth and innovation. Anne-Marie's theoretical background is a MSc Physics from University of Copenhagen. Board Change • Dec 30
High number of new and inexperienced directors There are 5 new directors who have joined the board in the last 3 years. The company's board is composed of: 5 new directors. No experienced directors. 1 highly experienced director. Co-Founder & Chair of the Board Jacob Jelsing is the most experienced director on the board, commencing their role in 2016. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. New Risk • Nov 15
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of German stocks, typically moving 13% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (13% average weekly change). Earnings have declined by 93% per year over the past 5 years. Reported Earnings • Aug 26
First half 2024 earnings released: kr.1.20 loss per share (vs kr.1.30 loss in 1H 2023) First half 2024 results: kr.1.20 loss per share. Revenue: kr.120.6m (up 19% from 1H 2023). Net loss: kr.20.1m (loss widened 11% from 1H 2023). New Risk • Aug 23
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -kr.50m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr.50m free cash flow). Share price has been highly volatile over the past 3 months (17% average weekly change). Earnings have declined by 93% per year over the past 5 years. Minor Risk Significant insider selling over the past 3 months (€4.1m sold). Recent Insider Transactions • Jul 05
Chief Executive Officer recently sold €4.1m worth of stock On the 2nd of July, Henrik Blou sold around 53k shares on-market at roughly €77.23 per share. This transaction amounted to 10% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. This was Henrik's only on-market trade for the last 12 months. Aankondiging • Jul 01
Boehringer Ingelheim and Gubra Announce Start of Clinical Development of A Potential First-In-Class, Triple Agonist, Obesity Treatment Boehringer Ingelheim and Gubra announced the launch of the Phase 1 study (NCT06352437) of BI 3034701, a long-acting triple agonist peptide with a potential to become a next-generation and first-in-class obesity treatment. More than 1 billion people worldwide live with obesity, and numbers are continuing to rise. Estimations show that by 2035, 24% of the entire world population will be affected by this disease. Obesity is a major risk factor for other cardiovascular, renal, and metabolic (CRM) diseases as well as for several types of cancer, which collectively are a leading cause of death worldwide. With the progression of BI 3034701, Boehringer Ingelheim further expands its pipeline of patient-centric solutions beyond weight loss for people living with obesity to achieve CRM health gain. BI 3034701 was developed together with Gubra involving licensed IP from Gubra, with Boehringer solely responsible for further development and commercialization globally. The study is the second project in the partnership with Gubra to advance to the clinic, following BI 1820237, for which Phase 1 clinical results were announced in 2023. The Phase 1, first-in-human, randomized, placebo-controlled trial, will assess safety, tolerability, and pharmacokinetics of the drug candidate (BI 3034701). The trial has 2 parts. Part A is open to healthy men between 18 and 55 years of age. Part B is open to people between 18 and 65 years of age with overweight or obesity who are otherwise healthy. Participants get different doses of BI 3034701 or placebo as an injection under the skin. In Part A, every participant gets a single dose. In Part B, every participant gets several doses of BI 3034701 and placebo. In this study, BI 3034701 is given to humans for the first time. The trial with an estimated 124. participants is expected to be completed in the second half of 2025. Additional information about the Phase 1 trial is available via ClinicalTrials.gov (NCT063524 37). The initiation of the phase 1 trial will release a milestone payment to Gubra. Reported Earnings • Mar 04
Full year 2023 earnings released: kr.2.94 loss per share (vs kr.0.37 profit in FY 2022) Full year 2023 results: kr.2.94 loss per share (down from kr.0.37 profit in FY 2022). Revenue: kr.205.0m (up 2.8% from FY 2022). Net loss: kr.44.5m (down kr.48.8m from profit in FY 2022). New Risk • Feb 09
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of German stocks, typically moving 7.5% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Revenue has declined by 11% over the past year. Minor Risk Share price has been volatile over the past 3 months (7.5% average weekly change). Board Change • Dec 01
High number of new and inexperienced directors There are 5 new directors who have joined the board in the last 3 years. The company's board is composed of: 5 new directors. 1 experienced director. No highly experienced directors. Co-Founder & Chair of the Board Jacob Jelsing is the most experienced director on the board, commencing their role in 2016. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Aankondiging • Nov 29
Gubra A/S Announces First Subject Dosed in Phase 1 Clinical Trial of Amylin Agonist (GUBamy) for the Treatment of Obesity Gubra A/S announced that the first human subject has been dosed with a new long-acting amylin agonist (GUBamy) as a potential treatment for obesity. This first clinical trial is a single ascending, dose-escalation, safety, and tolerability trial in healthy volunteers. The phase 1, First-In-Human, randomized, single ascending dose trial, will assess safety, tolerability, pharmacokinetics, and pharmacodynamics of GUBamy administered in lean to overweight but otherwise healthy subjects. The study will be conducted in up to 48 subjects divided in 6 cohorts at Quotient Sciences in Nottingham in the UK. The first cohort of subjects will be administered with a single dose of 0.5 mg GUBamy. After each dose cohort, a safety review will be performed and a decision about study progress and dose will be made for the next dose cohort. In addition to assessing the safety (primary objective), the trial will also evaluate the pharmacokinetic properties of GUBamy as well as the pharmacodynamic effects on gastric emptying and metabolic and hormonal changes. The trial is expected to complete enrollment mid-2024. Additional information about the Phase 1 trial is available via ClinicalTrials.gov (NCT06144684). GUBamy (GUB014295) is a long-acting amylin agonist for once weekly subcutaneous (s.c.) administration. GUBamy is in development for weight management in people living with obesity. The drug product is a sterile solution with a neutral pH. The physical and chemical properties of GUBamy solution is compatible with future co-formulation with other anti-obesity injectable drugs (e.g. GLP-1 agonists, dual and triple agonists etc.). Aankondiging • Nov 02
Gubra A/S Announces Board Appointments Gubra A/S announced that at its extraordinary general meeting held on November 1, 2023, approved the election of Monika Leesl and Astrid Haug as new members to the board of directors. The board of directors hereafter consists of Jacob Jelsing (chair), Alexander Thomas Martensen-Larsen (deputy chair), Henriette Rosenquist, Arndt Justus Georg Schottelius, Monika Lessl and Astrid Haug. Monika Lessl is an internationally experienced pharma executive with more than 15 years R&D leadership experience from Bayer AG (Germany). Monika is currently Executive Director of Bayer Foundation, and Senior Vice President; Head of Corporate R&D and Social Innovation Bayer AG. She holds a PhD in Biochemistry from the Max Planck Institute for Molecular Genetics in Berlin. In her former role as Head of Innovation Strategy she developed and led Bayer's Innovation Agenda to strengthen Bayer's Innovation capabilities and foster new business models. As Head of External Innovation Therapeutics at Bayer's pharmaceutical division she was responsible for creating the external innovation strategy and leading global partnering activities. Besides her executive role, she is a Board member of the Futurium, and acts as a jury member of the European Innovation Council and the German Ministry of Science and Education. Astrid Haug is an independent consultant in Astrid Haug ApS bureau, consulting private companies, organisations, start-ups and funds on digital strategy, social media, innovation, and green impact communication. She is the author of six books and recognised as an expert on radio and television debates and other media covering these topics. Astrid holds a cand. mag. In Media Sciences and is Member of Faculty at CBS/Børsen Executive Board education and member of the Digital Council at the Danish Academy of Technical Sciences. Besides that, she acts as board member in UNICEF Denmark (Chair), Symbion A/S, Nørrebro Teater and in two start-ups; Re-Zip Aps and Veras ApS (Veras vintage). Aankondiging • Sep 07
Gubra A/S Submits Clinical Trial Application (CTA) for First-In-Human Amylin Trial Gubra announced that a clinical trial application (CTA) for the anti-obesity amylin project has been submitted to the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. The clinical trial is expected to receive approval from the MHRA later in 2023 and the first human dose is planned for end of 2023. The planned phase 1 trial is a placebo-controlled dose escalation study testing single increasing subcutaneous doses of the novel long-acting amylin agonist GUC17. Participants in the trial will be healthy men with overweight/obesity. The primary objective of the trial is to investigate safety of GUC17. The trial will also evaluate the pharmacokinetic (absorption and distribution) profile of GUC17 and early signs of energy intake and metabolism of the test drug. Reported Earnings • Aug 26
First half 2023 earnings released First half 2023 results: kr.1.29 loss per share. Net loss: kr.18.1m (flat on 1H 2022). Aankondiging • Jun 29
Gubra A/S (CPSE:GUBRA) acquired Minigut Aps. Gubra A/S (CPSE:GUBRA) acquired Minigut Aps on June 29, 2023. The acquisition enables Gubra to perform minipig studies and adds a large animal model to Gubra’s CRO services. This includes both pharmacokinetic studies and microbiome studies, and over time additional minipig research models covering the disease areas within which Gubra operates.
Gubra A/S (CPSE:GUBRA) completed the acquisition of Minigut Aps on June 29, 2023. Aankondiging • Jun 10
Gubra A/S Announces Updates to Its Pipeline Gubra A/S announced updates to its R&D pipeline of internal and partnered projects. Most notably is the addition of a new CNS (orexin) peptide drug discovery project, now ready for partnering. The aim of the project is to develop an efficacious and safe peptide-based treatment for narcolepsy type 1. Gubra has developed a broad series of orexin peptides with very promising effects in animal models of narcolepsy which spurred the decision to advance the project into their R&D pipeline. The orexin peptide drug discovery project, that gains access to brain orexin receptors after a subcutaneous injection, has grown out of Gubra’s own streaMLine platform for rapid peptide drug discovery. Orexin is a hormone that helps regulate sleep-wake cycles. Certain sleeping disorders, such as narcolepsy type 1 (narcolepsy with cataplexy), are debilitating diseases with severe consequences for the quality of life of patients and their relatives. They are believed to be caused by the loss of a group of neurons deep in the brain producing orexin peptides. Narcolepsy type 1 is a rare chronic neurological disorder with a prevalence of 25-50 per 100,000. Aankondiging • May 19
Gubra A/S and Boehringer Ingelheim Share Phase 1 Results for BI 1820237 Gubra A/S and Boehringer Ingelheim presented at the European Congress on Obesity, ECO 2023 BI 1820237 a novel long-acting neuropeptide Y receptor type 2 (NPY2) agonist, has been evaluated in a phase 1 clinical trial. Results to be presented at the ECO 2023 congress in Dublin, Ireland. The trial showed no unexpected safety concerns, and positive effects on energy intake and gastric emptying. BI 1820237 originates from an ongoing collaboration between BoehringerIngelheim and Gubra A/S. at the 30th European Congress on Obesity (ECO 2023) in Dublin, Ireland, Boehringer Ingelheimer shares phase 1 results for BI 1820237, a long acting NPY2 receptor agonist drug candidate developed in collaboration with Gubra A/S". The phase 1 trial (NCT04903509) was a placebo-controlled study consisting of 3 parts: Part 1: testing single increasing subcutaneous doses of the novel NPY2 receptor agonist, part 2: increasing the number of participants in the high dose group and part 3: exploring low-to-medium doses of the NPY2 receptor agonist in combination with low-dose liraglutide. Participants in the trial were healthy men with overweight/obesity. The results show no unexpected safety or tolerability concerns with single doses of BI 1820237 with and without liraglutide; Adverse events were primarily gastro-intestinal in nature and the frequency increased with increasing dose. Treatment with BI 1820237 decreased energy intake and delayed gastric emptying in healthy men with overweight/ob obesity, supporting further investigations of the drug candidate. Aankondiging • May 12
Gubra A/S Provides Revenue Guidance for the Year 2023 Gubra A/S provided revenue guidance for the year 2023. for the year, the company expects Organic revenue growth 10% vs. 2022.